Cytel

JANUARY 17, 2024

Quantitative strategies can help inform decisions and optimize choices. Quantifying uncertainties and risks and planning for mitigating adaptations are necessary to maximize the chances of success while maintaining the required scientific rigor of pivotal trials.

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Clinical Development Trials Disease 59

Alta Sciences

FEBRUARY 19, 2025

Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S. It also outlines recommendations for drug-drug interaction assessments during clinical development, such as the assessment of appropriate biomarkers that reflect modulation of the target protein.

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Drug Development Clinical Pharmacology Immune Response Drugs 52

The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. About Sandoz.

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The Pharma Data

NOVEMBER 30, 2020

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn. Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax Forward Looking Statements.

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Clinical Development Vaccine Clinical Trials Immune Response 52

Conversations in Drug Development Trends

JANUARY 21, 2025

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Continuous feedback loops , like embedding Plan-Do-Check-Act (PDCA) cycles, foster iterative improvements and ensure sustainable outcomes.

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The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. For further information please visit www.gsk.com/about-us.

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The Pharma Data

JULY 8, 2021

The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Please see the full Prescribing Information.

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Clinical Trials FDA Approval Trials FDA 52

Cytel

NOVEMBER 8, 2023

Written by Natalia Muehlemann, Vice President, Clinical Development, and Ari Brettman, Senior Managing Director, Blackstone Life Sciences When working with investors, it’s critical that drug and device developers consider how their clinical trial design aligns with investment priorities. Let’s take a closer look:

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Clinical Trials Trials Clinical Development Science 59

The Pharma Data

MARCH 7, 2022

The topline data further characterize the long-term safety profile of fezolinetant and will inform future regulatory filings. 1 About Fezolinetant Fezolinetant is an investigational, oral nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause.

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The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. About Sandoz.

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Biosimilars Clinical Development Production Government 40

SugarCone Biotech

MARCH 2, 2025

Our skepticism was based on our understanding of the biology of those pathways and informed by observations made by the Antonia lab, several Roche groups and others that TGF- expression is sufficient to prevent T cell activation. The lead program here was bintrafusp alfa, now terminated.

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PPD

OCTOBER 16, 2023

Consent development: Informed consent is the most important step in the tokenization process. Part of the operational model includes selection of the tokenization vendor and determining what technology and data sources are required. If you don’t tokenize today, you may miss an opportunity to do so tomorrow.

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DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.

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Drug Development Clinical Trials Drugs Therapies 98

Drug Target Review

JULY 31, 2023

This targeted approach provides readers interested diseases or applications with tailored information and insights that align with their specific interests. By exploring the latest advancements and potential treatment approaches for their areas of interest, readers can deepen their understanding of disease-specific applications.

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Alta Sciences

NOVEMBER 15, 2024

Your Project History Be open to sharing relevant information about your study history and development plans. Be prepared to share necessary information about your study with the CRO,” says Chad. One of the first steps in this process is highlighting key milestones already achieved.

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Drug Development Clinical Trials Trials Drugs 52

Conversations in Drug Development Trends

MAY 1, 2024

The clinical trials sector prompted a recent modernization of ICH E8 and a subsequent renovation of ICH E6 to provide updated guidance that is appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources employed to support regulatory and other health policy decisions.

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Conversations in Drug Development Trends

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. Our approach is informed by our combined 30+ years in rare disease clinical development and our time in various stakeholder roles, such as scientists, CRAs, and project managers.

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Alta Sciences

JULY 22, 2024

Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development. jpg Tags Clinical Trials Weight 1

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The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. For additional information, please visit www.lexpharma.com. Safe Harbor Statement.

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Alta Sciences

MAY 29, 2024

How to Optimize Your Early-Phase Drug Development Program pmjackson Wed, 05/29/2024 - 20:32 The Challenges With Outsourcing Drug Development In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in preclinical and Phase I clinical development.

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Drug Development Drugs Clinical Development 52

PPD

SEPTEMBER 6, 2023

Examples include: Determining whether to use FSO or FSP models based on geography Combining FSP and FSO models based on therapeutic area, services and clinical trial phase Incorporating FSP resources into FSO studies when specific key roles (e.g.

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The Pharma Data

SEPTEMBER 16, 2020

executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C inhibitor sotorasib (AMG 510). Reese , M.D., On Monday, Sept. PDT , David M.

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Clinical Development Therapies Disease Research 52

New Drug Approvals

MAY 15, 2025

A final lipophilicity adjustment led to the discovery of CDZ173 (leniolisib), a potent PI3K selective inhibitor with suitable properties and efficacy for clinical development as an anti-inflammatory therapeutic. hdl : 10665/331020. World Health Organization (2017). hdl : 10665/330984.

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H1 Blog

JUNE 7, 2023

Performance data on principal investigators and clinical trial sites provides invaluable insights to pharma companies, helping them leverage successful sites and patient populations to maximize their clinical development feasibility and operations. There is a tendency to want to measure everything.” The Michael J.

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan.

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Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 52

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. FDA notes that the distinctions between responsibilities for these groups and DMCs should be clearly defined, particularly with respect to access to unblinded information.

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Clinical Trials Trials FDA Regulations 105

The Premier Consulting Blog

JULY 31, 2024

A key difference is that the Sponsor of a 505(b)(1) NDA owns or has right of reference to the safety and effectiveness information versus the Sponsor of a 505(b)(2) NDA leverages information from other drug approval packages and/or published information they do not own or have right of reference to.

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Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

Drug Target Review

JULY 20, 2023

From the 73 long COVID-associated genes, 42 hold potential for novel drug discovery, with 13 already targeted by drugs in clinical development pipelines. From the 73 long COVID-associated genes, 42 hold potential for novel drug discovery, with 13 already targeted by drugs in clinical development pipelines.

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Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. View the Driving Simulation Fact Sheet for more information.

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Clinical Trials Trials Clinical Pharmacology Clinical Development 52

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Other Questions. The Agency recommended that sponsors follow the requirements under 21 CFR 211.84(d)(2)

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Conversations in Drug Development Trends

AUGUST 23, 2023

Canary Advisors recommends including patient advisory boards, which a sponsor, CRO, or patient advocacy organization can create in the early stages of clinical development. Kahn explains these in-depth: “Before you have a clinical trial design finalized or sometimes before indication selection, you want to meet with patients,” he says.

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Drug Target Review

APRIL 3, 2024

The results from these trials will build the basis for addressing therapy-induced GDF-15-mediated resistance of cancers, a problem that represents a significant challenge across several therapeutic classes, including approaches currently in advanced stages of clinical development.

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The Pharma Data

JUNE 2, 2023

“The presentation of longer-term follow-up data from our pivotal studies and real-world evidence reinforce the potential of cell therapy across different blood cancers, lines of treatment and settings,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite. “We

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The Pharma Data

DECEMBER 27, 2020

The mitazalimab drug candidate has previously reported positive clinical data from two Phase I studies, one performed by Alligator, one performed by Janssen Biotech Inc., The information was submitted for publication, through the agency of the contact person set out above, at 11:00 a.m. The Company is headquartered in Lund, Sweden.

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Clinical Trials Clinical Development Trials Drugs 52

Drug Target Review

JUNE 6, 2023

Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy. Our deep interest in the interplay between immune cells, cytokines, and the tumour microenvironment has informed our clinical research to date as well as our IO pipeline program.

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The Pharma Data

JANUARY 4, 2021

For further information please contact: For Investors: About Polyphor Polyphor is a research-driven clinical-stage, Swiss biopharmaceutical company committed to discovering and developing first-in-class molecules in oncology and antimicrobial resistance leveraging the company’s leading macrocyclic peptide technology platform.

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Clinical Development Trials Treatment Research 52

PPD

JULY 18, 2023

Drug developers that tap an FSP model should ensure they select a partner that provides access to a deep bench of clinical development experts and services, as well as dedicated problem-solving for their issues. Regular review and management of KPIs and budget. Escalations and risk mitigation. Performance management.

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